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Prevention of Dental Caries Lesions With Fluoride Varnish in Erupting First Permanent Molars

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ClinicalTrials.gov Identifier: NCT02592278
Recruitment Status : Completed
First Posted : October 30, 2015
Last Update Posted : November 4, 2016
Sponsor:
Collaborator:
Colgate Palmolive
Information provided by (Responsible Party):
Universidad Iberoamericana

Brief Summary:

The aim of this study is to determine the effectiveness of fluoride varnishes in the prevention of dental caries lesions in erupting permanent first molars, in high-risk patients. Using as reference ICDAS criteria, when the success means that the surface maintain an ICDAS value 0 and failure that has change in ICDAS value 0 to 1.

Sample: The sample comprise 180 patients between 6-7 years old with high-risk of dental caries.

Study design: It proposed an experimental design randomized into 3 groups according to the frequency of topical fluoride application.(Group A: every 6 month; Group B: every 3 month; Group C: positive control).


Condition or disease Intervention/treatment Phase
Dental Caries Drug: Fluoride Varnish Drug: Control Group Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Prevention of Dental Caries Lesions With Fluoride Varnish in Erupting First Permanent Molars
Study Start Date : March 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arm Intervention/treatment
Experimental: Fluoride Varnish each 6 months
Fluoride Varnish application every 6 months.
Drug: Fluoride Varnish
Application of fluoride varnish every 3 and 6 months.
Other Name: Duraphat (Colgate)

Experimental: Fluoride Varnish each 3 months
Fluoride Varnish application every 3 months.
Drug: Fluoride Varnish
Application of fluoride varnish every 3 and 6 months.
Other Name: Duraphat (Colgate)

Active Comparator: Fluoride tooth paste
Control group. Twice a day brush with fluoride toothpaste.
Drug: Control Group
Twice a day brush with fluoride toothpaste.
Other Name: Colgate Total Toothpaste




Primary Outcome Measures :
  1. Number of first permanent molars with caries Lesion (taking into account ICDAS criteria) [ Time Frame: One year ]
    We are going to measure changed to decay surfaces in first permanent molars = ICDAS > 0 in a year.



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Ages Eligible for Study:   6 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Informed Consent from parents.
  • Child assent
  • High risk of dental caries
  • At least one sound first permanent molar (ICDAS=0)

Exclusion Criteria:

  • Bad behaviour
  • Any systemic condition, disability

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02592278


Sponsors and Collaborators
Universidad Iberoamericana
Colgate Palmolive
Investigators
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Principal Investigator: Ninoska Abreu Universidad Iberoamericana

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Responsible Party: Universidad Iberoamericana
ClinicalTrials.gov Identifier: NCT02592278     History of Changes
Other Study ID Numbers: 04-2015
First Posted: October 30, 2015    Key Record Dates
Last Update Posted: November 4, 2016
Last Verified: November 2016

Keywords provided by Universidad Iberoamericana:
Dental Caries
Fluoride Varnish
Preschool child
Prevention

Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
Fluorides, Topical
Sodium Fluoride
Listerine
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents